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Niche medical-device validation role with senior 10–12 years reduces competition despite Philips brand.
Medical device validation requires regulatory and QMS expertise, limiting cross-industry transferability.
Explicit 10–12 years and mandatory regulated validation/QMS experience create high resume filtering.
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Develop and maintain validation plans, protocols, scripts, and reports for computerized systems ensuring compliance with quality standards and regulatory requirements.
Conduct risk assessments to determine validation scope and ensure adequate testing coverage applying risk-based validation principles.
Evaluate system changes and enhancements for validation impact and assist with CAPAs related to computerized systems within a continuous improvement framework.
Bachelor's or Master's Degree in Mechanical Engineering, Industrial Engineering, Science, or equivalent.
10-12 years of experience in Quality Management Systems, Quality Audits, or related roles in highly regulated industries.
Experience in regulatory compliance, computerized system validation, and quality management processes.
This role requires full-time onsite presence at company facilities, working in-person at least 3 days per week.
Experienced in computerized system validation and quality assurance specifically within highly regulated industries.
Skilled in applying risk-based validation and capable of managing end-to-end validation documentation and compliance.
Comfortable working onsite regularly, indicating an ability to collaborate in a structured, office-based environment.